An interventional study of Muse-S™ headband system in Women's Health, Insomnia and Sleep Disturbance, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to female participants aged 45 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-01-26.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Treatment
The purpose of this study is to see if it is feasible for midlife women to wear a brain activity sensing headband (Muse-S) for management of sleep disturbances such as insomnia and sleep disruption
1,856 studies on the registry are indexed under Sleep Initiation and Maintenance Disorders; 594 are open to participants now.
This study's enrollment of 31 is below the median of 73 across 1,631 interventional studies indexed under Sleep Initiation and Maintenance Disorders.
Browse Sleep Initiation and Maintenance Disorders studies →Mayo Clinic is the lead sponsor of 3,218 studies on the registry; 670 are open to participants now.
Of its 445 completed or terminated interventional studies of FDA-regulated products, 313 (70%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Study participants will receive a new Muse-S headband system at study entry and will be asked to utilize it daily for a minimum of 10 minutes day for a period of 6 months (24 weeks). Three of the seven sessions per week will specifically be asked to be mind meditation.
Device: Muse-S™ headband system
Clinical grade, headband-style wireless EEG (electroencephalogram is a test used to evaluate the electrical activity in the brain) system and designed to interact with a mobile device (a smartphone or tablet). The device is a soft, stretchy band that fits around the forehead to the back of the head.
Change in Quality of Sleep
Measured using the self-reported Pittsburgh Sleep Quality Index (PSQI) to assess the severity of sleep disturbances. Possible scores range from 0 to 21 with higher scores indicating a worse outcome/more severe symptoms of sleep disturbance.
Time frame: Baseline, 3 months, 6 months
Sleep Impact
Measured using the self-reported ASCQ-Me Sleep Impact Short Form. The 5-item questionnaire used to assess functioning and wellbeing in accordance with sleep. The questions in this assessment tool ask how often they felt sleep impacted specific activities during the the past 7 days. Possible answers include: 5 - never; 4 - rarely; 3 - sometimes; 2 - often, and 1 - always. Possible scores range from 5 to 25, with higher scores indicating a better outcome.
Time frame: Baseline, 3 months, 6 months
Perceived Stress Levels
Measured using the self-reported Perceived Stress Scale (PSS). The 10-item questionnaire measures global perceived stress experienced by the participant over the preceding 30 days. The questions in this assessment tool ask how often the participant felt or thought a certain way during the past month. Possible answers include: 0 - never; 1 - almost never; 2 - sometimes; 3 - fairly often, and 4 - very often. Possible scores range from 0 to 40, with lower scores indicating a better outcome (less stress).
Time frame: Baseline, 3 months, 6 months
Change in Perceived Anxiety
Measured using the self-reported Generalized Anxiety Disorder Scale (GAD-7). The 7-item questionnaire assess severity of generalized anxiety disorder. Scoring is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." Total score for the seven items ranges from 0 to 21 where 0 is no anxiety, 1-4 is minimal anxiety, 5-9 is mild anxiety, 10-14 is moderate anxiety, and 15-21 is severe anxiety. With higher scores indicating more severe anxiety.
Time frame: Baseline, 3 months, 6 months
Sexual Function
Measured using the self-reported Female Sexual Function Index (FSFI). The 19-item questionnaire to assess the sexual functioning in women. The questions in this assessment tool ask participants about a specific sexual function within the past 4 weeks on a Likert scale range of 0-5. Total scores range from 2 to 36, with lower scores indicating worse sexual functioning.
Time frame: Baseline, 3 months, 6 months
Sexual Distress
Measured using the Female Sexual Distress Scale (FSDS-R). The 13-item questionnaire to assess sexually related personal distress over the pas 30 days. The questions in this assessment tool asks how often the participant felt during the past month. Possible answers include: 0 - never; 1 - rarely; 2 - occasionally; 3 - frequently, and 4 - always. Possible scores range from 0 to 60, with higher scores indicating greater level of distress.
Time frame: Baseline, 3 months, 6 months
Change in Quality of Life
Measured using the self-reported Patient Health Questionnaire (PHQ-9). The 9-item questionnaire used to assess severity of depression. Scoring is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." Total score for the seven items ranges from 0 to 27 where 0 is no depression, 1-4 is minimal depression, 5-9 is mild depression, 10-14 is moderate depression, and 15-19 is moderately severe depression and 20-27 severe depression. With higher scores indicating more severe depression.
Time frame: Baseline, 3 months, 6 months
| Milestone | Muse-S Headband System for Management of Sleep Disturbances |
|---|---|
| Started | 31 |
| Completed | 14 |
| Not completed | 17 |
| Withdrew: Withdrawal by subject | 17 |
Measured using the self-reported Pittsburgh Sleep Quality Index (PSQI) to assess the severity of sleep disturbances. Possible scores range from 0 to 21 with higher scores indicating a worse outcome/more severe symptoms of sleep disturbance.
| score on a scale | Muse-S Headband System for Management of Sleep Disturbances |
|---|---|
| Baseline to 3 Months | -3 (-4 to -2) |
| Baseline to 6 Months | -4 (-9 to -3) |
| 3 Months to 6 Months | -1 (-3 to 0) |
Measured using the self-reported ASCQ-Me Sleep Impact Short Form. The 5-item questionnaire used to assess functioning and wellbeing in accordance with sleep. The questions in this assessment tool ask how often they felt sleep impacted specific activities during the the past 7 days. Possible answers include: 5 - never; 4 - rarely; 3 - sometimes; 2 - often, and 1 - always. Possible scores range from 5 to 25, with higher scores indicating a better outcome.
| score on a scale | Muse-S Headband System for Management of Sleep Disturbances |
|---|---|
| Baseline | 18 (8 to 25) |
| 3 Months | 22 (14 to 25) |
| 6 Months | 23 (14 to 25) |
Measured using the self-reported Perceived Stress Scale (PSS). The 10-item questionnaire measures global perceived stress experienced by the participant over the preceding 30 days. The questions in this assessment tool ask how often the participant felt or thought a certain way during the past month. Possible answers include: 0 - never; 1 - almost never; 2 - sometimes; 3 - fairly often, and 4 - very often. Possible scores range from 0 to 40, with lower scores indicating a better outcome (less stress).
| score on a scale | Muse-S Headband System for Management of Sleep Disturbances |
|---|---|
| Baseline | 16 (1 to 27) |
| 3 Months | 12 (2 to 21) |
| 6 Months | 12 (4 to 22) |
Measured using the self-reported Generalized Anxiety Disorder Scale (GAD-7). The 7-item questionnaire assess severity of generalized anxiety disorder. Scoring is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." Total score for the seven items ranges from 0 to 21 where 0 is no anxiety, 1-4 is minimal anxiety, 5-9 is mild anxiety, 10-14 is moderate anxiety, and 15-21 is severe anxiety. With higher scores indicating more severe anxiety.
| score on a scale | Muse-S Headband System for Management of Sleep Disturbances |
|---|---|
| Baseline to 3 Months | -2 (-3 to -1) |
| Baseline to 6 Months | -2 (-4 to 0) |
| 3 Months to 6 Months | 0 (-5 to 3) |
Measured using the self-reported Female Sexual Function Index (FSFI). The 19-item questionnaire to assess the sexual functioning in women. The questions in this assessment tool ask participants about a specific sexual function within the past 4 weeks on a Likert scale range of 0-5. Total scores range from 2 to 36, with lower scores indicating worse sexual functioning.
| score on a scale | Muse-S Headband System for Management of Sleep Disturbances |
|---|---|
| Baseline | 18 (2 to 34) |
| 3 Months | 18 (4 to 34) |
| 6 Months | 21 (3 to 33) |
Measured using the Female Sexual Distress Scale (FSDS-R). The 13-item questionnaire to assess sexually related personal distress over the pas 30 days. The questions in this assessment tool asks how often the participant felt during the past month. Possible answers include: 0 - never; 1 - rarely; 2 - occasionally; 3 - frequently, and 4 - always. Possible scores range from 0 to 60, with higher scores indicating greater level of distress.
| score on a scale | Muse-S Headband System for Management of Sleep Disturbances |
|---|---|
| Baseline | 23.5 (13 to 53) |
| 3 Months | 24 (13 to 50) |
| 6 Months | 18 (12 to 41) |
Measured using the self-reported Patient Health Questionnaire (PHQ-9). The 9-item questionnaire used to assess severity of depression. Scoring is calculated by assigning scores of 0, 1, 2, and 3 to the response categories, respectively, of "not at all," "several days," "more than half the days," and "nearly every day." Total score for the seven items ranges from 0 to 27 where 0 is no depression, 1-4 is minimal depression, 5-9 is mild depression, 10-14 is moderate depression, and 15-19 is moderately severe depression and 20-27 severe depression. With higher scores indicating more severe depression.
| score on a scale | Muse-S Headband System for Management of Sleep Disturbances |
|---|---|
| Baseline to 3 Months | -2 (-3 to -1) |
| Baseline to 6 Months | -2 (-3 to -1) |
| 3 Months to 6 Months | 0 (-3 to 1) |
Collected over Adverse events were collected from the time of informed consent through study completion, approximately 6 months.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Muse-S Headband System for Management of Sleep Disturbances | 0/31 (0%) | 0/31 (0%) | 0/31 (0%) |
| Age, Categorical(Participants) | Muse-S Headband System for Management of Sleep Disturbances |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 31 |
| >=65 years | 0 |
| Sex: Female, Male(Participants) | Muse-S Headband System for Management of Sleep Disturbances |
|---|---|
| Female | 31 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | Muse-S Headband System for Management of Sleep Disturbances |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 31 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Muse-S Headband System for Management of Sleep Disturbances |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 1 |
| White | 29 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(participants) | Muse-S Headband System for Management of Sleep Disturbances |
|---|---|
| United States | 31 |
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